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Medtronic Steerable Guidewire (2013-10-21)
- Starting date:
- October 21, 2013
- Posting date:
- November 27, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36949
Recalled products
- Cougar XT Steerable Guidewire
- Cougar LS Steerable Guidewire
- Thunder Steerable Guidewire
- Attain Hybrid Guide Wire
Reason
Medtronic has identified the potential for an issue with a specific subset of lot numbers of the medtronic interventional wires and attain hybrid guidewires where the polytetrafluoroethylene (PTFE) coating could delaminate and detach from the guidewire.
Affected products
A. Cougar XT Steerable Guidewire
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- CGRXT190HJ
- CGRXT190HS
- CGRXT190J
- CGRXT190S
- CGRXT300HJ
- CGRXT300HS
- CGRXT300J
- CGRXT300S
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
B. Cougar LS Steerable Guidewire
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- CGRLS190HJ
- CGRLS190HS
- CGRLS190S
- CGRLS300HS
- CGRLS300S
C. Thunder Steerable Guidewire
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- THNDR190J
- THNDR190S
- THNDR300J
- THNDR300S
D. Attain Hybrid Guide Wire
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- GWR419478
- GWR419488
- GWR419688